HS-001

HS-001 is an investigational allogeneic cell therapy developed by Heartseed Inc. for the treatment of advanced heart failure, particularly in patients with ischemic heart disease or dilated cardiomyopathy. The therapy consists of highly purified cardiomyocyte spheroids derived from induced pluripotent stem cells (iPSCs). Heartseed employs a proprietary Metabolic Selection process to achieve nearly 99% purity of the cardiomyocytes, which are then formed into micro-tissues (spheroids) to enhance engraftment and survival upon transplantation into the myocardium. The goal of HS-001 is to remuscularize the failing heart, electrically integrate with host tissue, and restore cardiac function. The therapy is currently being evaluated in the Phase 1/2 LAPiS clinical trial in Japan. A global collaboration with Novo Nordisk for the development of HS-001 was established in 2021 but was subsequently terminated in 2025.

Other names

human induced pluripotent stem cell-derived cardiomyocyte spheroidsallogeneic iPSC-derived cardiomyocyte cardiac spheresregenerative cardiac spheres